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510(k) K233167

LW Implant System – Abutment by Ossvis Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2024
Date Received
September 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Ossvis Co., Ltd.

  • K242703 — LW Pre-milled Abutment (December 5, 2024)
  • K242379 — LL Implant System (November 7, 2024)
  • K233808 — LW Narrow Implant System (July 31, 2024)
  • K231235 — LW UCLA Abutment (September 15, 2023)
  • K231079 — LW Retraction Cap (September 14, 2023)
  • K223924 — LW Implant System (August 8, 2023)

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